Week 1, Ch 2

Question 1

If you wanted a comprehensive medical reference of published drug standards, what might you use?

Answer 1

A Pharmacopoeia

Question 2

What is the center for drug evaluation and research called?

Answer 2

The FDA

Question 3

What government site determines the safety and efficacy of drugs?

Answer 3

The FDA

Question 4

What does the FDA do?

Answer 4

Determines the safety and efficacy of drugs.

Question 5

If you wanted to identify an extreme adverse reaction of a drug, where would you find it on the label?

Answer 5

The Black Box Warning

Question 6

The Black Box warning is used to identify what?

Answer 6

An extreme reaction from a drug

Question 7

True or False:
Because of the unknown effects of herbal medicine, the FDA uses more strict evaluations for Herbal supplements.

Answer 7

False.
Herbal supplements have much less strict evaluations

Question 8

There are 4 stages of drug approval. What are they?

Answer 8

1.) Pre-Clinical Investigation
2.) Clinical Investigation
3.) Review of New Drug Application
4.) Post-Marketing

Question 9

The Pre-Clinical evaluation usually takes:
a.) 1-3 years
b.) 2-10 years
c.) 2 months - 7 years

Answer 9

a.) 1 - 3 years is pre-Clinical

2-10 years is Clinical evaluation
2 months-7 years is Review of NDA

Question 10

The Pre-Clinical stage determines the drug-dose range, and is tested on what?

Answer 10

Human cells and animals.
NOT HUMANS!!

Question 11

The examination of a drug’s adverse effects begins in which stage of the drug approval process?

Answer 11

Pre-Clinical stage

Question 12

True or False:
Results in the pre-clinical trials are considered conclusive, because the next stage involves trials on humans.

Answer 12

False:
The pre-clinical trials results are considered inconclusive.

Question 13

True or False:
Clinical Investigation is the start of human trials.

Answer 13

True

Question 14

Clinical Investigations has 3 stages. Which stage determines the dosage and risks?

Answer 14

Stage 1

Question 15

In which stage of the Clinical Investigation trials do the Clinical Investigators address concerns about the drug’s efficacy and safety?

Answer 15

Stage 3

Question 16

True or False:
During stage 2 of the Clinical Trials, the drugs are tested in small groups between 2-7 people.

Answer 16

False:
Stage 2 involves testing a large group of people.

Question 17

True or False:
Clinical Trials are started with the clients with the targeted ailment to test for drug benefits and the speed of recovery.

Answer 17

False:
Clinical Trials begin with the healthiest patients first, then on the people with the targeted ailment.

Question 18

In Clinical trials, do the people in the trials have to know that they are in a study?

Answer 18

Yes

Question 19

True or False:
If the drug has shown to be effective in Clinical evaluation without serious side effects, it enters market circulation and moves on to the Post-Marketing Surveillance phase.

Answer 19

False:
It moves on to the NDA review phase before it can be put to market.

Question 20

The time it takes to review the drug during the NDA review stage can be between 2 months and 7 years. But on average, how long does it usually take?

Answer 20

17 to 24 months.

Question 21

True or False:
Research on human populations is continued through the Post-Market Surveillance stage, and can go on for several years.

Answer 21

True:
Research is continued through post-marketing surveillance and can go on from 10 to 20 years!

Question 22

An Addiction to a drug is:
a.) An overwhelming feeling to use a drug repeatedly.
b.) A Physiological/Psychological need for drugs
c.) The Nervous System adaptation to drug dependance.

Answer 22

a.) Addiction is an overwhelming feeling to use a drug repeatedly.

Question 23

Dependency on a drug is:
a.) A compelling desire for a drug
b.) An overwhelming desire to use a drug repeatedly.
c.) A Physiological/Psychological need for drugs

Answer 23

c.) Dependency is a physiological/psychological need for drugs.

Question 24

What’s the difference between Addiction and the Dependance of a drug?

Answer 24

Addiction is an overwhelming urge to use a drug repeatedly.

Dependance is a physiological/Psychological need to use a drug.

Question 25

Physical Dependance is:
a.) The Nervous System adaptation that results in dependance.
b.) The intense, compelling desire to continue drug use.

Answer 25

a.) Physical dependance is the Nervous System adapting to the repeated use of drugs, resulting in dependance.

Question 26

Psychological Dependance is:
a.) The overwhelming urge to use a drug repeatedly.
b.) An Intense, compelling desire to continue drug use.
c.) The Nervous System adaptation that results in dependance.

Answer 26

b.) Psychological Dependance is an intense, compelling desire to continue drug use.

Question 27

Withdrawal is affiliated with which type of dependance?

Answer 27

Physical Dependance.

Question 28

True or False:
Psychological Dependance is when the Nervous System adapts to repeated drug use, resulting in dependance.

Answer 28

False:
Physical Dependance is the Nervous System adapting to repeated drug use.

Question 29

True or False:
Controlled substances are non-addictive Analgesic’s controlled via strict prescription.

Answer 29

False:
Controlled Substances are highly addictive and frequently abused.

Question 30

True or False:
Schedule V drugs are the Least addictive controlled substances, and Schedule 1 drugs are the Most addictive.

Answer 30

True:
-Schedule 1 drugs have no therapeutic value and are very addictive.
-Schedule 5 drugs are the least addictive, and require no prescriptions

Question 31

Heroin, LSD, Marijuana (cannabis) and ecstasy are all examples of what drug schedule?

Answer 31

Schedule 1

Question 32

Cocaine, Fentanyl, Oxy, and methamphetamine are all examples of what drug schedule?

Answer 32

Schedule 2

Question 33

Differentiate the Schedule 1 drugs from the Schedule 2 drugs:
Heroin, Cocaine, Marijuana (cannabis) and Fentanyl, LSD, Oxy, Ecstasy, Methamphetamine, Amphetamine, Peyote

Answer 33

Schedule 1: Heroin, Marijuana (cannabis), LSD, Ecstasy, Peyote

Schedule 2: Cocaine, Fentanyl, Oxy, Methamphetamine, Amphetamine

Question 34

Which of these Drug Schedules requires a prescription for use?
a.) Schedule 3
b. Schedule 4
c.) Schedule 5
d.) Schedule 3 & 4
e.) Schedule 4 & 5
f.) Schedule 5 & 3

Answer 34

d.) Schedules 3 and 4 require prescriptions to use.

Question 35

To be classified as a Schedule 3 drug, a product has to contain LESS than how many milligrams of Hydrocodone, and no MORE than how many milligrams of Codeine?

Answer 35

-Less than 15mg of Hydrocodone
-No more than 90mg of Codeine

Question 36

Ketamine, Buprenorphine and Anabolic Steroids are examples of what type of drug schedule?

Answer 36

Schedule 3

Question 37

If Cough preparations do not contain more than 200mg of Codeine per 100mL (or) mg, then it is considered what drug schedule?

Answer 37

Schedule 5

Question 38

What is wrong with this scenario?

A patient makes a request at a pharmacy to fill a drug order. The patient hand the pharmacy tech a piece of paper and states that “My doctor is giving me a refill.” The doctor’s note is electronically signed and calls for the order of 15mg of Fentanyl. The patient states that his drug evaluation history for the Fentanyl should be in the system.

Answer 38

-Doctors do not give refill orders
-Notes for a drug order must ALWAYS be handwritten
-A request for a controlled substance, specifically a schedule 2 drug like Fentanyl, would require an up-to-date medical evaluation from the provider

Question 38

Alprazolam (Xanex) and Diazepam (Valium) are examples of what drug schedule?

Answer 38

Schedule 4

Question 39

The Five categories of risk that a drug possesses to the fetus of a pregnant woman are called the what?

Answer 39

The Teratogenic Classifications.

Question 39

The Teratogenic Classifications are what?

Answer 39

The Five categories of risk that a drug possesses to the fetus of a pregnant woman.

Question 40

The Teratogenic Classifications are A, B, C, D, X. Choose which options are which.

1.) No risk, fetal harm is remote.
2.) Positive evidence of human fetal risk. Used in emergency situations (trauma, life threatening situation).
3.) Animal studies show no evidence or risk in humans; Slight risk in animals
4.) Harm to human fetus in definite. Do not use in pregnancy.
5.) Risk cannot be ruled out in either human’s or animal fetus.

Answer 40

1.) Teratogenic A
2.) Teratogenic D
3. Teratogenic B
4. Teratogenic X
5.) Teratogenic C